How to Manage Clinical Trials from Start-Up to Close-Out

CTM Course: Supplemental Library

Providing training beyond what hiring companies offer, this course will give you professional guidance and proven methods to successfully manage a clinical trial from start to finish.

Interested in this course? Email us at [email protected]

Course curriculum

1. Office Hours 9/23/22
2. Office Hours 9/30/22
3. Office Hours 10/7/22
4. Office Hours 10/14/22
5. Office Hours 10/21/22
6. Office Hours 1/27/23
7. Office Hours 2/10/23
8. Office Hours 2/24/23
9. Office Hours 3/24/23
10. Office Hours 5/5/23
11. Office Hours 5/19/23
12. Office Hours 9/8/23
13. Office Hours 9/22/23
14. Office Hours 10/6/2023
15. Office Hours 2/9/2024
16. Office Hours 2/23/2024
17. Office Hours 4/12/2024
18. Office Hours 5/3/24
19. Office Hours 5/17/24
20. Office Hours 9/13/24
21. Office Hours 9/27/24
22. Office Hours 2/7/2025
23. Office Hours 2/8/2026
1. Sponsor CTM vs. CRO CTM: Understanding the Difference in Perspective
1. RFP Activity
2. Study Award Activity
3. Site Selection Letters
4. Investigatory Meeting Planning Activity
5. Creating Study Plans
6. Full Time Equivalent (FTE)
7. Kick-Off Meeting Agenda Activity
8. Monitoring Guidelines
9. Pre-Study Visit Follow-Up Letter and Site Non-Selection Letter
10. Project Resourcing Activity
11. Request for Proposal
12. What a Study Start-Up Specialist Does
13. Budgets and Contracts for Doctor Negotiations
14. CTM Works with CTA and Sponsor CTM on SIV Prep
15. Tips for Reviewing a Study Protocol
16. Budget Review
17. Timing of Meetings
1. Interim Analysis
2. Invoice Review
3. Study Team Meetings
4. Documents a CTM Should Reference for Invoice Reviews
5. How a CTM is Involved When There is an SAE
6. FAQ Logs
7. How Often Should CTMs Meet with Their CRAs?
8. How Often Should CTMs Meet with Their CTA?
9. How Often Should CTMs Meet with Data Management?
10. Invoicing Issue: What Would You Do?
11. Protocol Amendments
1. eTMF Closure and Cleanup
2. Interim Analysis vs Database Lock
3. Timing of eTMF Quality Review
4. Final Quality Review
5. Supply Return
6. When Study is Wrapping Up, Is CTM Notified When Team Will Shrink
7. Working with Sites During Final eTMF QC
1. Explanations of Central IRBs in the US
2. Color-Coding Your Calendar
3. How to Start Each Day as a CTM
4. Organizing and Color-Coding Tips in Outlook
5. Importance of Communication and Sharing Information
6. Study Transitions
7. Training for New CTMs at a Large vs Small Company
8. Phase I Nuances and Challenges for CTMs
9. Phase II Nuances and Challenges for CTMs
10. Phase III Nuances and Challenges for CTMs
11. Phase IV Nuances and Challenges for CTMs
12. 5 Systems CTMs Need to Know
13. Taking PTO
14. Working with Global Teams
15. What Should You Do When You Have Technical Difficulties During a Call You are Leading?
16. Best Practices for an Audit
17. How to Organize Your Outlook Inbox as a Clinical Research Professional
18. 3 Tips for Prioritizing Your Day
1. CRAs and CTMs - Understanding and Elevating This Critical Relationship - Guest Speaker Elizabeth Weeks-Rowe
2. eTMF Session #1: Understanding TMF Systems and Documents - Guest Speaker Saleem Batti
3. eTMF Session #2: Understanding TMF Management Plan - Guest Speaker Saleem Batti
1. Peak Periods for Hiring
2. Best Way to Apply for a Job in the US if I Live Outside of the US
3. Contract Work Mock Interview for a Consultant CTM Role - Andy with Black Diamond
4. Translating Minimal CTM Experience to Knowledge When Applying for CTM Role
5. How Recruiters Find Roles
6. How to Answer a Question About Your Experience if You Don't Have the Experience
7. How to Answer Situational Questions
8. Mock Interview for a CTM Role
9. Resume Writing Best Practices
10. Role Play - Recruiter and Contractor
11. Should You Include References on Your Resume
12. Thoughts on Cover Letters
13. Why to Interview with More Than One Company and Why to Always Negotiate
14. Why You Need to Be Your Biggest Advocate
15. Live Training - Interview with Andy Garcia from Black Diamond Networks
16. How to Diplomatically Push Back When Asked to Take on More Than is Feasible
17. Typical Career Trajectory for a CTM in a Large Company
18. Job Description Review - Clinical Research Leader - LinkedIn
19. Interview with Recruiter Jennifer Lane - Advanced Clinical
20. Asking Questions During an Interview
21. Recap of Interview - Facilitator's Rationale on Responses Given During an Interview and Salary Negotiation Tips
22. Manager Wants to Put You on Two Studies in Start-Up - How Should You Respond?
23. Line Manager vs Project Manager
24. Types of Clinical Research Interviews
25. Full Interview with Clinical Research Recruiter Andy Garcia from Black Diamond Including Mock Interview
26. Advice for People Transitioning into the CTM Role from Other Clinical Research Roles
27. Tell Me About Yourself - How to Answer This Question
28. Pay Cycles for Contractors
29. Number of Years a CTM Needs to Become a CTM Contractor
30. Interview with Clinical Research Consultants Sam Larberg and Chloe Giffin from Medix
1. Access to Interviewing Videos
2. How to Structure Your Responses for CRO CTM Interviews
3. How to Structure Your Responses for Sponsor CTM Interviews When You Are Overseeing a CRO

About this course

Free
113 lessons
36.5 hours of video content

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CTM Course: Supplemental Library

Course curriculum

Live Q & A (Office Hour) Sessions

Sponsor CTMs vs. CRO CTMs

Study Initiation

Study Conduct

Study Close-Out

General Considerations

Guest Instructors

Career Recommendations

Clinical Research Interviewing Video Series

About this course

Discover your potential, starting today